H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery

March 30, 2026 updated by: Electronic Waveform Lab

Efficacy of H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery: A Prospective, Single-center, Double-Blinded, Randomized Controlled Trial

The goal of this intent-to-treat study is to evaluate the efficacy of H-Wave Device Stimulation following rotator cuff repair surgery. It is hypothesized that HWDS initiated immediately upon home arrival following rotator cuff repair will not only result in earlier range of motion recovery, but also in better pain relief, medication reduction, sleep quality, and functional recovery. The participants will be randomized into two groups: (a) Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications, (b) Routine post-surgical care plus H-Wave® Device Stimulation (HWDS); and will be followed for 3 months post-surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Sano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael J. Dempewolf, DO, MBA
        • Sub-Investigator:
          • Matthew Dagget, DO, MBA
        • Sub-Investigator:
          • Andrew Witte, DO, MBA
        • Sub-Investigator:
          • Matthew Cullen, DO
        • Sub-Investigator:
          • John Swab, DO
        • Sub-Investigator:
          • Christopher Eckland, DO
        • Sub-Investigator:
          • Daniel Farrell, MS, MD, FAAOS
    • Missouri
      • Kansas City, Missouri, United States, 64151
        • Sano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael J. Dempewolf, DO, MBA
        • Sub-Investigator:
          • Matthew Dagget, DO, MBA
        • Sub-Investigator:
          • Andrew Witte, DO, MBA
        • Sub-Investigator:
          • Matthew Cullen, DO
        • Sub-Investigator:
          • John Swab, DO
        • Sub-Investigator:
          • Christopher Eckland, DO
      • Lee's Summit, Missouri, United States, 64064
        • Sano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael J. Dempewolf, DO, MBA
        • Sub-Investigator:
          • Matthew Dagget, DO, MBA
        • Sub-Investigator:
          • Andrew Witte, DO, MBA
        • Sub-Investigator:
          • Matthew Cullen, DO
        • Sub-Investigator:
          • John Swab, DO
        • Sub-Investigator:
          • Christopher Eckland, DO
      • Raymore, Missouri, United States, 64083
        • Sano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael J. Dempewolf, DO, MBA
        • Sub-Investigator:
          • Matthew Dagget, DO, MBA
        • Sub-Investigator:
          • Andrew Witte, DO, MBA
        • Sub-Investigator:
          • Matthew Cullen, DO
        • Sub-Investigator:
          • John Swab, DO
        • Sub-Investigator:
          • Christopher Eckland, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of full-thickness, or partial requiring surgical detachment, rotator cuff tear
  2. Primary rotator cuff repair (reattachment), with or without other necessary procedures, (e.g., biceps tenodesis, distal clavicle resection)
  3. Age 18-64 at time of enrollment
  4. Body mass index (BMI) <40 Kg/m2
  5. Females, sexually active and of childbearing age, must be willing to use a reliable form of birth control throughout study duration; Males, sexually active with partners of childbearing age must be willing to use contraceptive measures
  6. Be willing and capable of providing written informed consent to participate in the clinical study based on voluntary agreement, following thorough explanation of subject participation
  7. Be willing and capable of completing subjective evaluations, reading, understanding, and signing written questionnaires and informed consent
  8. Be willing and capable of complying with study-related requirements, procedures, and follow-up visits

Exclusion Criteria:

  1. Excluded diagnosis and/or procedure and/or symptoms including infection, tumor, partial-thickness rotator cuff tear (not requiring surgical detachment), or other primary non-rotator cuff tear related shoulder surgery
  2. Morbid obesity with BMI ≥40 Kg/m2
  3. Pregnancy as determined by urine testing (unless surgically sterile or post-menopausal)
  4. Actively breastfeeding or desiring pregnancy during the study
  5. Prior H-Wave® device stimulation use
  6. Use of other home devices (e.g., TENS) within 2 weeks of screening visit
  7. Major psychological or psychiatric disorder
  8. Unresolved major secondary gain issues (e.g., social, financial, or legal) including worker's compensation with attorney representation
  9. Addiction or substance abuse history to opioids, controlled substances, alcohol, or illicit drugs
  10. Injectable steroids within 8 weeks of screening visit
  11. Implanted pacemaker, SCS, or other devices deemed unfit for inclusion by principal investigator
  12. History of progressive neurological disease
  13. History of immunosuppressive medication/treatment or cancer diagnosis within 5 years
  14. History of uncontrolled autoimmune disorders
  15. History of organ or hematologic transplantation
  16. Reported pain in other area(s) and/or medical condition(s) that could interfere with accurate pain reporting, study procedures, or confound study evaluations
  17. Participated in another clinical study or received treatment with any investigational product within 30 days
  18. From a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to employees (temporary, part- time, full-time) or family members of the research staff conducting the study, or of the sponsor, contract research organization, or IRB/IEC
  19. Has any other condition(s) that, in the investigator's opinion, might indicate that the subject is unsuitable for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Device: Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Routine post-surgical care plus H-Wave® Device Stimulation (HWDS)
Active Comparator: Routine post-surgical care
Other: Routine post-surgical care
Routine post-surgical care: standard protocols per procedure, including access to opioid and non-opioid pain medications

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain Medication Usage
Time Frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Amount of opioids (converted into morphine milligram equivalents) and other polypharmacy will be recorded, and change in usage of pain medications at follow-up visit(s) compared to baseline will be determined.
Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in pain intensity assessed via Visual Analogue Scale (VAS)
Time Frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
0-10 Visual Analog Scale (0 = no pain, 10 = worst imaginable) will be used. Change in Pain intensity at follow-up visit(s) compared to baseline will be evaluated.
Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in pain intensity assessed via Brief Pain Inventory (BPI)
Time Frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
BPI Pain Items will be used (0- no pain, 10- pain as bad as you can imagine). Change in Pain intensity at follow-up visit(s) compared to baseline will be evaluated.
Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in Function assessed via American Shoulder and Elbow Surgeons Score (ASES)
Time Frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Patient-reported improvement in functional improvement assessed via ASES. It involves pain and activities of daily living (0- unable to do, 3- not difficult) questionnaire. Change in function at follow-up visit(s) compared to baseline will be evaluated.
Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in Single Assessment Numeric Evaluation (SANE)
Time Frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Patient will report their affected joint and opposite side as a percentage of normal (0 to 100% scale with 100% being normal). Change at follow-up visit(s) compared to baseline will be evaluated.
Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Change in functional outcomes assessed via University of California, Los Angeles (UCLA) Shoulder Score
Time Frame: Baseline, 2 months and 3 months
UCLA shoulder score records patient-reported date (pain, function and satisfaction) along with clinician-reported findings (range of motion). Scores range from 0 to 35 with a score of 0 indicating worse shoulder function and 35 indicating better shoulder function. Change at follow-up visit(s) compared to baseline will be evaluated.
Baseline, 2 months and 3 months
Change in Sleep Quality assessed via Brief Pittsburg Sleep Quality Index (B-PSQI)
Time Frame: Baseline, 6-8days, 3-4weeks, 2 months and 3 months
Rated on a scale of 0-21 (Score of 0-5: Good sleeper; >5: Poor sleeper). Change in sleep quality at follow-up visit(s) compared to baseline will be evaluated.
Baseline, 6-8days, 3-4weeks, 2 months and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Active/Passive Range of Motion (AROM/PROM)
Time Frame: Baseline, 2 months and 3 months
Clinician will record Active and Passive Range of Motion for both Unaffected and Affected Shoulders. Change at follow-up visit(s) compared to baseline will be evaluated.
Baseline, 2 months and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Electronic Waveform Lab

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stephen M. Norwood, MD, FAAOS, Orthopaedic Surgeon
  • Principal Investigator: Michael J. Dempewolf, DO, MBA, Sano Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EWL - 2026/PORCR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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